Digitally enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: A randomised controlled trial.

BACKGROUND: Digitally enabled rehabilitation may lead to better outcomes but has not been tested in large pragmatic trials. We aimed to evaluate a tailored prescription of affordable digital devices in addition to usual care for people with mobility limitations admitted to aged care and neurological rehabilitation. METHODS AND FINDINGS: We conducted a pragmatic, outcome-assessor-blinded, parallel-group randomised trial in 3 Australian hospitals in Sydney and Adelaide recruiting adults 18 to 101 years old with mobility limitations undertaking aged care and neurological inpatient rehabilitation. Both the intervention and control groups received usual multidisciplinary inpatient and post-hospital rehabilitation care as determined by the treating rehabilitation clinicians. In addition to usual care, the intervention group used devices to target mobility and physical activity problems, individually prescribed by a physiotherapist according to an intervention protocol, including virtual reality video games, activity monitors, and handheld computer devices for 6 months in hospital and at home. Co-primary outcomes were mobility (performance-based Short Physical Performance Battery [SPPB]; continuous version; range 0 to 3; higher score indicates better mobility) and upright time as a proxy measure of physical activity (proportion of the day upright measured with activPAL) at 6 months. The dataset was analysed using intention-to-treat principles. The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000936628). Between 22 September 2014 and 10 November 2016, 300 patients (mean age 74 years, SD 14; 50% female; 54% neurological condition causing activity limitation) were randomly assigned to intervention (n = 149) or control (n = 151) using a secure online database (REDCap) to achieve allocation concealment. Six-month assessments were completed by 258 participants (129 intervention, 129 control). Intervention participants received on average 12 (SD 11) supervised inpatient sessions using 4 (SD 1) different devices and 15 (SD 5) physiotherapy contacts supporting device use after hospital discharge. Changes in mobility scores were higher in the intervention group compared to the control group from baseline (SPPB [continuous, 0-3] mean [SD]: intervention group, 1.5 [0.7]; control group, 1.5 [0.8]) to 6 months (SPPB [continuous, 0-3] mean [SD]: intervention group, 2.3 [0.6]; control group, 2.1 [0.8]; mean between-group difference 0.2 points, 95% CI 0.1 to 0.3; p = 0.006). However, there was no evidence of a difference between groups for upright time at 6 months (mean [SD] proportion of the day spent upright at 6 months: intervention group, 18.2 [9.8]; control group, 18.4 [10.2]; mean between-group difference -0.2, 95% CI -2.7 to 2.3; p = 0.87). Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life. No adverse events were reported in the intervention group. Thirteen participants died while in the trial (intervention group: 9; control group: 4) due to unrelated causes, and there was no evidence of a difference between groups in fall rates (unadjusted incidence rate ratio 1.19, 95% CI 0.78 to 1.83; p = 0.43). Study limitations include 15%-19% loss to follow-up at 6 months on the co-primary outcomes, as anticipated; the number of secondary outcome measures in our trial, which may increase the risk of a type I error; and potential low statistical power to demonstrate significant between-group differences on important secondary patient-reported outcomes. CONCLUSIONS: In this study, we observed improved mobility in people with a wide range of health conditions making use of digitally enabled rehabilitation, whereas time spent upright was not impacted. TRIAL REGISTRATION: The trial was prospectively registered with the Australian New Zealand Clinical Trials Register; ACTRN12614000936628.

Video and computer-based interactive exercises are safe and improve task-specific balance in geriatric and neurological rehabilitation: a randomised trial.

QUESTION: Does adding video/computer-based interactive exercises to inpatient geriatric and neurological rehabilitation improve mobility outcomes? Is it feasible and safe? DESIGN: Randomised trial. PARTICIPANTS: Fifty-eight rehabilitation inpatients. INTERVENTION: Physiotherapist-prescribed, tailored, video/computer-based interactive exercises for 1 hour on weekdays, mainly involving stepping and weight-shifting exercises. OUTCOME MEASURES: The primary outcome was the Short Physical Performance Battery (0 to 3) at 2 weeks. Secondary outcomes were: Maximal Balance Range (mm); Step Test (step count); Rivermead Mobility Index (0 to 15); activity levels; Activity Measure for Post Acute Care Basic Mobility (18 to 72) and Daily Activity (15 to 60); Falls Efficacy Scale (10 to 40), ED5D utility score (0 to 1); Reintegration to Normal Living Index (0 to 100); System Usability Scale (0 to 100) and Physical Activity Enjoyment Scale (0 to 126). Safety was determined from adverse events during intervention. RESULTS: At 2 weeks the between-group difference in the primary outcome (0.1, 95% CI -0.2 to 0.3) was not statistically significant. The intervention group performed significantly better than usual care for Maximal Balance Range (38mm difference after baseline adjustment, 95% CI 6 to 69). Other secondary outcomes were not statistically significant. Fifty-eight (55%) of the eligible patients agreed to participate, 25/29 (86%) completed the intervention and 10 (39%) attended > 70% of sessions, with a mean of 5.6 sessions (SD 3.3) attended and overall average duration of 4.5hours (SD 3.1). Average scores were 62 (SD 21) for the System Usability Scale and 62 (SD 8) for the Physical Activity Enjoyment Scale. There were no adverse events. CONCLUSION: The addition of video/computer-based interactive exercises to usual rehabilitation is a safe and feasible way to increase exercise dose, but is not suitable for all. Adding the exercises to usual rehabilitation resulted in task-specific improvements in balance but not overall mobility. REGISTRATION: ACTRN12613000610730.

Effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation: a protocol for the Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial.

INTRODUCTION: People with mobility limitations can benefit from rehabilitation programmes that provide a high dose of exercise. However, since providing a high dose of exercise is logistically challenging and resource-intensive, people in rehabilitation spend most of the day inactive. This trial aims to evaluate the effect of the addition of affordable technology to usual care on physical activity and mobility in people with mobility limitations admitted to inpatient aged and neurological rehabilitation units compared to usual care alone. METHODS AND ANALYSIS: A pragmatic, assessor blinded, parallel-group randomised trial recruiting 300 consenting rehabilitation patients with reduced mobility will be conducted. Participants will be individually randomised to intervention or control groups. The intervention group will receive technology-based exercise to target mobility and physical activity problems for 6 months. The technology will include the use of video and computer games/exercises and tablet applications as well as activity monitors. The control group will not receive any additional intervention and both groups will receive usual inpatient and outpatient rehabilitation care over the 6-month study period. The coprimary outcomes will be objectively assessed physical activity (proportion of the day spent upright) and mobility (Short Physical Performance Battery) at 6 months after randomisation. Secondary outcomes will include: self-reported and objectively assessed physical activity, mobility, cognition, activity performance and participation, utility-based quality of life, balance confidence, technology self-efficacy, falls and service utilisation. Linear models will assess the effect of group allocation for each continuously scored outcome measure with baseline scores entered as a covariate. Fall rates between groups will be compared using negative binomial regression. Primary analyses will be preplanned, conducted while masked to group allocation and use an intention-to-treat approach. ETHICS AND DISSEMINATION: The protocol has been approved by the relevant Human Research Ethics Committees and the results will be disseminated widely through peer-reviewed publication and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12614000936628. Pre-results.